Otitis Media With Effusion With Hearing Impairment, Recurrent Acute Otitis Media
Conditions
Brief summary
There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material. No-one knows if there are differences between the different kinds of tubes regarding complications. The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications. To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.
Interventions
DEVICEInsertion of a specific type of ventilation tube through the tympanic membrane
The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear. The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested. The first combination will test: Shepard tube (double flanged, Fluoroplastic) vs Donaldson tube (double flanged, silicone) The second combination will test: Straight tube (single flanged, Fluoroplastic) vs Armstrong (single flanged, silicone) The third combination will test: Armstrong (single flanged, silicone) vs Donaldson tube (double flanged, silicone) The fourth combination will test: Straight tube (single flanged, Fluoroplastic) vs Shepard tube (double flanged, Fluoroplastic)
Sponsors
Centre for clinical research Vastmanland
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 1-10 planned for bilateral ventilation tubes
Exclusion criteria
* Ongoing ear infection * Previous insertion of ventilation tube
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete expulsion of the ventilation tube from the tympanic membrane | 45 months |
Secondary
| Measure | Time frame |
|---|---|
| Need for tube extraction (pain or infection) | 45 months |
| Pain leading to health care contact | 45 months |
| Persistent tympanic membrane perforation | 45 months |
| Obstruction of the tube | 45 months |
| Presence of myringosclerosis | 45 months |
| Tube related ear infection | 45 months |
Countries
Sweden
Outcome results
None listed